Non-Small-Cell Lung CarcinomaNCT01185639
Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer
A study testing stereotactic body radiation therapy in people with Non-Small-Cell Lung Carcinoma and Liver Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Liver Cancer, Adrenal Cancer
- What is being tested?
- stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to 27 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General
- Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
- Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
- Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
- Maximum of number of lesions per patient will be 5 total. .
- Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study enrollment are also eligible. Patients with history of brain metastases must have an MRI showing no active brain metastases within 80 days of study enrollment. Patients with a history of brain metastases may have up to 5 extracranial sites of disease except for those with an untreated primary tumor where section 3.1.3.3 will also apply.
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- Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more than 3 active extracranial metastatic lesions other than the primary site and regional lymph nodes.
- Age ≥ 18 years old
- Performance Status 0-2 (ECOG)
- A signed study specific consent form is required.
- Lung (only applies to patients with active lung lesions)
- Patients cannot have more than 3 lung lesions
- Local failure after surgical resection will be consider a metastatic lesion for purposes of protocol inclusion.
- All lung lesions must be visible on CT imaging
- Cumulative diameter of lung lesions must be <7cm
- Patients may have active mediastinal disease in a single mediastinal nodal station if he/she has not received prior mediastinal RT
- Must meet criteria regarding status of primary tumor site described in section 3.1.9.
- Must be able to anticipate achieving SBRT dosimetry guidelines
- Must have adequate lung function defined within 90 days of enrollment as: (1) Forced Expiratory Volume in 1 second (FEV1) >30% of predicted or >800 Ml, (2) diffusing capacity of the lung for carbon monoxide (DLCO) >30 % predicted and (3) no evidence of actively worsening respiratory status
- Liver (only applies to patients with active liver lesions
- Patients cannot have more than 3 liver lesions
- All active liver lesions must be discrete on CT or MRI imaging
- Combined diameter of all liver lesions must be <6cm
- Must be able to anticipate achieving SBRT plan per dosimetry guidelines for the liver.
- Liver function tests (AST, ALT, total bilirubin) should be within ≤ 3 times the upper limit of normal (ULN)
- Serum Albumin must be >2.5g/dL
- Patients cannot have active ascites.
- Adrenal Gland
- Unilateral adrenal disease
- Must be able to anticipate achieving the SBRT plan per dosimetry guidelines.
- Bone Lesions
- Treatment of any bone lesion is permissible if it is anticipated that the dosimetry guidelines can be met.
- Spine and Paraspinal lesions
- Patients cannot have more than 3 vertebrae or paraspinal sites involved (each involved vertebral body or paraspinal site is scored as 1 site of disease)
- Must be no clinical or radiographic evidence of spinal cord compression
- If spinal metastases is within previously irradiated field, there must be a 6 month interval between prior radiation course and study enrollment
- Prior spinal cord maximum dose at level of vertebral disease must be ≤50Gy
Who cannot join
- Primary tumor progression on first-line chemotherapy
- Patients with complete response to first-line chemotherapy with no measurable target for SBRT
- >5 metastatic lesions or >3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
- Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
- Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
- Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease are ineligible.
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- Pleural effusion known to be malignant or visible of chest xray.
- Untreated brain metastases
- Bilateral adrenal metastases
- Metastases in other sites not considered amenable to SBRT
- Patients with liver metastases cannot have received prior upper abdominal radiation
- Prior radiation to spine (most commonly in treatment of primary lung cancer), cannot have received >50Gy to the spinal cord at the level of current vertebral metastases
- Clinical or radiographic evidence of spinal cord compression are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Weight loss (>10% of body weight) in the prior 3 months.
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, 28401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC
This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.
- Conditions
- Non-Small-Cell Lung Carcinoma, Liver Cancer, Adrenal Cancer
- Being tested
- stereotactic body radiation therapy
- Keywords
- lung cancer, metastatic, SBRT, Stereotactic body radiation therapy, liver, spine, adrenal, bone cancer, Spinal Column
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Liver Neoplasms, Adrenal Gland Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
Also called Elekta Bodyframe, Cyberknife
For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
| Study group | Role | What they receive |
|---|---|---|
| SBRT for metastatic NSCLC | Experimental | SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions Receives: Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or <25%or original size; partial >30% decrease of target lesion; stable <30% decreased of target lesion and; local failure increase >20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.
Measured: up to 2 years
Secondary outcomes (4)
To Assess Physical Function for This Cohort of Patients
Using the Vulnerable Elders Survey (VES-13) A 13-item self-reporting questionnaire includes age, self-rated health, limitations in physical function and disability to assess for deterioration of physical function/health. Scoring for the VES-13 is as follows: Total scores are summed together based on self-rated health (0-1), physical function (0-2), functional disability (0-4), (range from 0 to 7). A total score of 3 or more identifies participants as vulnerable to the risk of decline of physical function.
Measured: up to 3 months after treatment
Number of Participants With Local Control
Local control (LC) of SBRT-treated lesions will only be assessed in patients with at least 4-months of radiographic follow-up.
Measured: up to 2 years
Overall Survival
Overall survival will be reported with an exact 95% confidence interval.
Measured: up to 4 years
Impact of Treatment on Quality of Life (FACT-L)
Using the Functional Assessment of Cancer Therapy - Lung (FACT-L) a 36-item self-administered questionnaire evaluating physical, social/family, emotional, and functional well-being; subscales (symptoms, cognitive function, regret of smoking) on a five-point scale from 0 (not at all) to 4 (very much). Maximum score 136. Subscale scores added to obtain total score. The higher the score the greater the impact on the quality of life.
Measured: up to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion27 Jun 2016
- Study completion27 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Blackstock, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185639
- Sponsor's protocol ID
- IRB00013994
- Other IDs
- NCI-2010-01877, CCCWFU 62110
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2010
- Last updated
- 29 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Petty WJ, Urbanic JJ, Ahmed T, Hughes R, Levine B, Rusthoven K, Papagikos M, Ruiz JR, Lally BE, Chan M, Clark H, D'Agostino RB Jr, Blackstock AW. Long-Term Outcomes of a Phase 2 Trial of Chemotherapy With Consolidative Radiation Therapy for Oligometastatic Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):527-535. doi: 10.1016/j.ijrobp.2018.06.400. Epub 2018 Jul 10.
PubMed 30003996
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT01185639
- Acronym / sponsor ID
- IRB00013994
- Conditions
- Non-Small-Cell Lung Carcinoma, Liver Cancer, Adrenal Cancer
- Keywords
- lung cancer, metastatic, SBRT, Stereotactic body radiation therapy, liver, spine, adrenal, bone cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 27 Jun 2016 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT for metastatic NSCLC | Experimental | Radiation: stereotactic body radiation therapySBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- General
- Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
- Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
- Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
- Maximum of number of lesions per patient will be 5 total. .
Key exclusion criteria (16 listed)
- Primary tumor progression on first-line chemotherapy
- Patients with complete response to first-line chemotherapy with no measurable target for SBRT
- >5 metastatic lesions or >3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
- Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
- Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiation therapyAlso: Elekta Bodyframe, CyberknifeFor lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques | Radiation | SBRT for metastatic NSCLC |
Primary outcome
Progression-free Survival
Time frame: up to 2 years
Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or <25%or original size; partial >30% decrease of target lesion; stable <30% decreased of target lesion and; local failure increase >20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.
4 secondary outcomes
To Assess Physical Function for This Cohort of Patients
Time frame: up to 3 months after treatment
Number of Participants With Local Control
Time frame: up to 2 years
Overall Survival
Time frame: up to 4 years
Impact of Treatment on Quality of Life (FACT-L)
Time frame: up to 3 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30003996Petty WJ, Urbanic JJ, Ahmed T, Hughes R, Levine B, Rusthoven K, Papagikos M, Ruiz JR, Lally BE, Chan M, Clark H, D'Agostino RB Jr, Blackstock AW. Long-Term Outcomes of a Phase 2 Trial of Chemotherapy With Consolidative Radiation Therapy for Oligometastatic Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):527-535. doi: 10.1016/j.ijrobp.2018.06.400. Epub 2018 Jul 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Blackstock, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiation therapy in people with Non-Small-Cell Lung Carcinoma and Liver Cancer, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.